Aphaia Pharma Finishes Enrollment for Phase 2 Obesity Trial Arm 2

Aphaia Pharma, a clinical-stage company specializing in precision-targeted drug formulations aimed at restoring endocrine balance for treating obesity and related metabolic disorders, has successfully completed enrollment for the second arm of its Phase 2 trial. This trial is designed to assess the safety and efficacy of Aphaia's oral glucose formulation in promoting weight loss among individuals with obesity. The company had previously concluded enrollment for the first part of the trial in April, which involved a once-daily 12g dose of the oral formulation (APHD-012).

The Phase 2 trial, known as NCT05385978, follows a randomized, double-blind, placebo-controlled, proof-of-concept study format. It is divided into two main arms: Arm 1 and Arm 2. Arm 1 comprises two cohorts, totaling 174 patients, who are randomly assigned to receive either APHD-012 or a matching placebo once daily before their main meals over six or twelve months. Arm 2, which includes four cohorts with 54 additional patients, involves twice-daily administration of either 6g (APHD-006) or 8g (APHD-008) of the glucose formulation or their respective placebos.

The primary goal of the trial is to measure the change from baseline in the percentage of body weight compared to the placebo group. Additionally, the study will explore secondary endpoints related to multiple metabolic diseases commonly associated with obesity.

Steffen-Sebastian Bolz, M.D., Ph.D., the chief scientific officer of Aphaia Pharma, expressed satisfaction with the on-schedule completion of enrollment for Arm 2. He emphasized the significant need for obesity treatments beyond hormone replacement therapy. Dr. Bolz believes that their oral glucose formulation has the potential to offer long-term benefits with minimal side effects by restoring the body's natural release of metabolically active hormones involved in satiety and glucose metabolism. Arm 2 aims to refine the dosing regimen further to optimize treatment response, especially if the circadian rhythm's effect on treatment efficacy is confirmed.

Aphaia's lead drug candidate is a proprietary oral glucose formulation that targets specific parts of the small intestine to restore nutrient-sensing signaling pathways. This process stimulates the release of a broad spectrum of enteric hormones, which regulate various homeostatic functions, including appetite, hunger, satiety, glucose metabolism, and energy expenditure. Key hormones involved include glucagon-like-peptide 1 (GLP-1), peptide tyrosine-tyrosine (PYY), glicentin, and oxyntomodulin (OXM).

Aphaia Pharma, headquartered in Switzerland, Canada, and Puerto Rico, focuses on developing proprietary precision-targeted drug formulations to restore endogenous hormone release from nutrient-sensing cells in the gastrointestinal tract. This approach aims to treat and prevent metabolic disorders such as obesity and associated diseases. The oral glucose formulation has already demonstrated its ability to safely restore endogenous hormone release in individuals with obesity. It is currently being evaluated in two Phase 2 trials: one for chronic weight management in individuals with obesity and another to improve glucose tolerance in individuals with prediabetes. The versatile nature of Aphaia's technology platform also opens up opportunities to develop treatments for various disease patterns.

Aphaia anticipates releasing topline data for Arm 1 in Q3 2024 and for Arm 2 in Q4 2024, further advancing the company's mission to provide effective treatment solutions for obesity and related metabolic disorders.